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    1K views166 pages

    Alcon Infiniti - Operator's Manual PDF

    Uploaded by

    Kader Smaili

    Copyright:

    © All Rights Reserved
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    QNeE! NIT L VISION SYSTEM Operator's Manual Manufacturer: Alcon Laboratories, Ine. 6201 South Freeway Fort Worth, Texas 76134-2099 USA. Produced By: Alcon Laboratories, Ine. 15800 Alton Parkway Irvine, California 92618-3818 USA. Telephone: 949/753-1393 800/832-7827 FAX: 949/753-6614 8065751606 R, CATALOG NUMBER ‘905-210-006 B, TEXT ONLY EU Authorized Representative: Alcon Laboratories (U-K.) Ltd Boundary Way, Hemel Hempstead Hertfordshire, HP2 7UD United Kingdom C Eon Directive 93/42/EEC © 2009 Alcon, Inc. Infiniti Vision System Operator's Manual 8065751606 MANUAL REVISION RECORD. DATE REVISION _ECN NUMBER AND DESCRIPTION July 2009 N 20091225 - Initial release of operator's manual with catalog number 8065751606, and 905-210-006 text (applies to Anfiniti® Vision System consoles with software version 2,04). This manual includes the Ozil® IP feature, and the 23 gauge Infiniti® UltraVit* probe. September 2009 R 20091528 - Add note on text cover sheet to inspect per generic QIP manual, END USER LICENSE AGREEMENT: ‘This product contains software licensed from Microsoft Corporation. * Registered in the U.S. Patent & Trademark Office. ** Mackool is a trademark of Richard J. Mackool, M.D. SmartPhaco is a registered trademark of Micro Medical Devices, Inc. SmartPhaco is licensed from Micto Medical Devices, Inc, Cycoloy and Lexan are registered trademarks of Sabic Innovative Plastics IP i 18065751606 TABLE OF CON Untroduction. 6... eee e cece cece eect eee eeeee ee eet eter General Information 2 ‘Warnings and Cautions , 17 Product Service. = AAG Limited Warranty . . 1.17 SECTION TWO - DESCRIPTION PAGE Introduction... INFINITP VISION SYSTEM CONSOLE AND ACCESSORIES Console Rear Panel Footswiteh ... Remote Control . Handpicoes, Tips, and Infusion Sleeves Fluidic Management System . a Infinii® AquaLase® Balanced Salt Solution Bottle . Consumable Pak Configurations . Infinit®® VideOverlay System. z INFINITE VISION SYSTEM OPERATOR INTERFACE Front Display Panel and Touch Screen Setup Screen and its Functions Doetor Name . Handpiece Type. Tip Type Procedure Type Cataract Grade ...... Irrigation Controls... . Metrics Display ‘| Footswitch Button. .......... Custom Button ..... Setup Status Window Setup Steps ........ Surgery Screen and its Functions Main Window ........ Surgery Control Window . . Fluidics Controls . Surgery Controls : Adjust Button and Information Bat... Surgery Controls Window with V/A Steps i Surgery Controls Window with Vitrectomy Steps. Surgery Controls Window with Coagulation Steps . Surgery Menu . Setup Button. .. enero eeer tale ieee ate 13065767606 ii Procedural Step Buttons............4 Stationary Step Buttons .. . Surgery Modes............ Ultrasound (U/S) Mode of Operation NeoSoniX® Mode of Operation ..... OZit® Mode of Operation . OZi?* IP Feature... Aquatase® Liquefaction Mode of Operation . Irrigation/Aspiration Mode of Operation . : Fill Mode of Operation for Inrigation/Aspiration . ‘Coagulation (Coag) Mode of Operation . . Anterior Vitrectomy Mode of Operation... . Introduction. Power Up Sequence Initial System Setup ... Standard Phacoemulsfication Setup. Standard AquaLase® System Setup. . Intigation/Aspiration Handpiece Setup . Anterior Vitrectomy Probe Setup Coagulation Handpiece Setup. . Introduction.............05 AL Upon Completion of the Day's Surgical Schedule . . 2 Care and Cleaning, ..... He 14d Sterilization Instructior AS Fuse Replacement... . we eeeenenes teens + AO Introduction cect : - Su Problem Conditions ........ Se ees Advisories....... : . 58 Warnings 0... eeceeeee 215.10 Faults. . vee S10 Catalog Numbers and Descriptions .... a + 62 Alphabetical Listing of Topics ............ 7A wv (20667516068 LIST OF FIGURES igure 1-1 Figure 1-2 Figure 1-3, Figure 1-4 Figure 2-1 Figure 2-2 Figure 2-3 Figure 2-4 Figure 2-5 Figure 2-6 Figure 2-8 Figure 2-9 Figure 2-10 Figure 2-11 Figure 2-12 Figure 2-13 Figure 2-14 Figure 2-15 Figure 2-16 Figure 2-17 gure 2-18 igure 2-19 Figure 2-20 Figure 2-21 Figure 2-22 Figure 2-23 Figure 2-24 Figure 2-25 Figure 2-26 Figure 2-27 Figure 2-28 Figure 2-29 Figure 2-30 Figure 2-31 Figure 2-32 Figure 2-33 Figure 2-34 Figure 2-35 Figure 2-36 Figure 2-37 Figure 2-38 Figure 2-39 Figure 2-40 ‘The Irjiniti® Vision System ir Icons Used With the Infinit? Vision System... Labeling on Infiniri® Vision System Coagulation Power Outputs ....... “121 The Console The Front Connector Panel The Rear Panel ..... The Right Side Panel... : The Accurus*/Legacy® and Infiniti Footswitches ....... Footswitch Cable Routing nee eee Diagram of Footpedal Positions . . Footswitches Used with the Injiniti® Vision System The Remote Control . wees ‘The Remote Control Keys - Proper Orientation of ‘Two Halves of Remote Control « The Remote Control Settings Dialog OZif® Torsional Handpiece . . Infinit?® NeoSoniX® Handpiece ....... Infini® Ultrasonic (U/S) Handpiece . TurboSonics® Tips H AquaLase® Liquefaction Handpiece Infinit@® U/S HIP with Infusion Sleeve and BSI. Utiraflow"™* LT Handpiece and Tips : Uliraflow™* IT HP with infusion sleeve, reusable V/A tip, and tip adapter... 2.25 Ulirafiow™ * O-ring tool with large and small O-rings : Ultraflow™ * SP Handpiece Infiniti® Vitrectomy Probes . Single use bipolar brush . : ‘The Infiniti® Ultrasound Fluidic Management System (FMS) The AquaLase*/Balanced Salt Solution Bottle ........ VideOverlay Front Panel. VideOverlay Rear Panel . Wall Outlet Adapters. . Standard VideOverlay Connection Diagram High Definition VideOverlay Connection Diagram He ‘The Infinit? Vision System Front Display Panel and Touch Screen. Navigating the Infinisi® Vision System User Screens... Functional Areas of the Setup Screen Bottle Height Measurement Metrics Dialog Sereen . . Footswitch Buttons Dialogs Footswitch Treadle Dialogs Setup Screen with Custom Drop List Mena Doctor Settings Dialog Screen - General Tab ‘3065751608 igure 2-41 Figure 2-42 Figure 2-43 Figure 2-46 Figure 2-47 Figure 2-47 Figure 2-48 Figure 2-50 Figure 2-51 Figure 2-52 Figure 2-53 Figure 2-54 Figure 2-55 Figure 2-56 Figure 2-57 Figure 2-58 Figure 2-59 Figure 2-60 Figure 2-61 Figure 2-62 Figure 2-63 Figure 2-64 Figure 2-65 re 2-66 ure 2-67 Figure 2-68 Figure 2-69 Figure 2-70 Figure 2-71 Figure 2-72 Figure 2-73 Figure 2-74 Figure 2-75 Figure 2-76 Figure 2-77 sure 2-78 sure 2-79 Figure 2-80 Figure 2-81 Figure 2-82 Figure 2-83 Figure 2-84 Figure 2-85 igure 2-86 Figure 2-87 OZit* Torsional Function Before Phaco Doctor Settings Dialog Screen - Steps Tab Doctor Settings Dialog Screen - Defaults Tab Doctor Settings Dialog Screen - Advanced Tab Copy/Delete Dialog . : Copy/Delete Dialog with Enabled and Disabled Tips... System Settings Dialog. peter IV Pole Extender Settings. Sound Settings Dialog AquaLase® Occlusion Settings Dialog . About Dialog z Functional Area of the Setup Status Window Functional Areas of the Setup Steps Window - Functional Areas of the /nfiniti® Vision System Surgery Screen Surgery Control Window : Lower and Upper Limits. . Surgery Menu . U/S Footpedal Control ‘The Ultrasound Continuous Surgery Screen . The Ultrasound Pulse Surgery Screen .. ‘The Ultrasound Burst Surgery Screen .. ‘The U/S Custom Pulse Surgery Screen NeoSoniX® Footpedal Control... . “The NeoSoniX* Continuous Surgery Screen. The NeoSoniX® Pulse Surgery Screen .. ‘The NeoSoniX® Burst Surgery Screen oe ‘The NeoSoniX* Custom Pulse Surgery Screen OZit® Footpedal Control. ‘The OZi!® Continuous Surgery Screen” The OZit® Pulse Surgery Screen . Phaco Duty Cycle (% Time On) Not Adjustable , The OZil® Burst Surgery Screen The OZit® Custom Pulse Surgery Screen . Surgery Sereen with OZil® IP Enabled . . OZit® IP Dialog . OZil® IP Dialog . The AquaLase® Surgery Screen . AquaLase® Footpedal Control . . : ‘The Irrigation/ Aspiration Surgery Screen. Irrigation/Aspiration Footpedal Control ‘The Coagulation Screen ............ Coagulation Footpedal Control. Anterior Vitrectomy Footpedal Control : Anterior Vitrectomy Sereen with Vit Probes in Drop Down List . Anterior Vitreetomy Surgery Screen Using 20 Gauge Infinii® Vitrectomy Probe. Anterior Vitrectomy Surgery Screen Using 23 Gauge Inj UliraVit® Probe . Vitrectomy Setup Screen. Beaten "8065751606 Figure U/S Tip/Wrench Assembly Figure Mackool** Tips Figure Protective Cap Removal Figure 3-4 Preparing Test Chamber and Pl Figure 4-1 Footswitch Cleaning... 143 Figure 5-1 Advisories Screen Figure 5-2. Warnings Screen Figure 5-3. Faults Screen. . Figure 5-4 Troubleshooting Guide . LIST OF TABLES TABLE# TITLE, PAGE # Table 1-1 Guidance and Manufacturer's Declaration - Electromagnetic Emissions... . 4 Table 1-2 Guidance and Manufacturer's Declaration - Electromagnetic Immunity... . 15 Table 1-3 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the /rfinid® Vision System Table 1-4 Specifications . . : ‘Table 1-5. Abbreviations Used with the Jnfinit® Vision System Table 2-1 Table of Footpedal Positions .. Table 2-2 Programming the Footswitch Treadle Table 2-3 Parameters in Surgery Controls Area Table 5-1 Problem Conditions Table 5-2 Error Codes 8085751606 vil ONE INTE PREFACE ‘This operator's manual is your written guide to the /njiniti® Vision System and considers all options available to the customer; therefore, when reading this manual, ignore the options which do not apply to your specific unit, Please read the entire manual carefully before operating the instrument. Recommended settings are given only 2s guidelines, and are not meant to restrict the surgeon; however, before trying other settings, the surgeon and support personnel should be experienced with the system and familiar with the new settings. NOTE: If an inconsistency exists between the instructions in the operator's manual and the Directions For Use (DFU) supplied with a consumable pak or accessory, follow the DFU. Equipment improvement is an on-going process and, as such, changes may be made to the ‘equipment after this manual is printed Pay close attention to Warnings, Cautions, and Notes in this manual. A WARNING! statement is written to protect individuals from bodily harm. A Caution statement, with the CAUTION heading centered above the text, is written to protect the instrument from damage. A NOTE: is written to bring attention to highlighted information. If you have questions, or want additional information, please contact your local Alcon representative or the Alcon Technical Services Department at: Alcon Laboratories, Inc. 15800 Alton Parkway Irvine, California 92618 (049) 753-1393 FAX (049) 753-6614 CAUTION: US, Federal Law restricts this device to sale by or on the order of a physician, vi LAST PAGE OF THIS SECTION "8085751606 ONe INTE TRODUCTION Alcon’s Infinit Vision System is an ophthalmic surgical instrument designed to be reliable, safe, and easy to operate. The Jnfiniti® Vision System provides four modes for cataract lens extraction using AquaLase®, OZil* torsional, NeoSoniX®, and high performance U/S hhandpicces. This instrument has been developed to be user friendly, combining hardware that is easy to install and maintain along with software that increases the effectivity of the user, The Infiniti® Vision System is intended for use in small incision cataract lens extraction surgical procedures. This system allows the surgeon to emulsify and aspirate the lens in the eye, while replacing aspirated uid and Jens material with balanced salt solution. This process maintains a stable (inflated) eye chamber volume. Using system controls the surgeon regulates the amount of power applied to the handpiece tip, the rate of aspiration, vacuum, and the flow of BSS? or BSS*Plus irrigation solution. The system controls include a footswitch to enable the surgeon to control irrigation flow, aspiration rate, phaco power, vitrectomy cut rate, and coagulation power. Figure 1-1. The infinit? Vision System ‘3085751606 1” GENERAL INFORMATION ‘The Infiniti? Vision System is designed for use in anterior segment procedures that require simultaneous cataract lens extraction, ittigation, und aspiration, as well as associated procedures such as vitrectomy and coagulation. It was developed with a dual Purpose: to make it simple to operate, and to allow the surgeon tremendous versatility and control. The system is designed to allow the surgeon to customize the veatment of every patient. Following are key features of the /rfiniti® Vision System: + Customized cataract lens removal options: ~ OZil® torsional handpiece with ultrasonic torsional oscillations which can be used exclusively or alternated with traditional phaco. - AquaLase® liquefaction device handpiece, technology, and accessories. ~ Infiniti® NeoSoniX* handpiece combining the features of a phaco handpiece with sonic oscillations. : - High performance Infiniti® U/S handpiece: 40 kHz, piezoeléctrie, slim, lightweight, autoclavable. + Advanced fluidics with quick, smooth control of peristaltic aspiration. + Fully programmable, multi-microprocessor control. + Modularized fluidic connections achieved with the disposable Fluidie Management System (FMS). + Emulation of venturi-like fluidic performance. + Ability to drive a high performance Infinis?® vitrectomy guillotine cutter. + Bipolar coagulation capability. + Several traditional modalities of ultrasonic power control including continuous, pulsed, and “burst” application of ultrasonic power, as well as duty eycle management. + Automated IV pole, controlled via the front panel, footswitch, or remote control. ‘+ Linear footswitch control of ultrasonic power in U/S steps (sophisticated control loop offers low-end control). + Linear footswitch control of aspiration flow rate (AFR) in WA, VIT, and lens removal modes. + Linear footswitch control of vacuum in I/A, VIT, and lens removal modes, + On-demand continuous irrigation. + Programmable, pressurized reflux via the footswitch. + Ability to set vacuum levels and aspiration flow rates to desired levels in phaco, WA, and VIT steps. + Ability to switch between surgical steps using touch screen, remote, ot footpedal. + Emission of variable tones for confirmation of system operational status. + Voice confirmation during surgical step or mode changes. + Flat screen, active matrix color LCD with touch screen display that is tiltable and rotatable, + High-tech graphical user interface. + Multi-channel wireless remote control. 12 ‘8065751606 ONE In Abbreviation Descriptions Many of the abbreviations used in this manual and on the Infiniti? Visi described in Table 1-5. Icons are identified in Figure 1-2. mn System are Accessory Equipment Accessory equipment connected to or used with this equipment must be certified according to the respective IEC Standard (¢.g,, IEC 950 for data processing equipment, and IEC 60601-1 for medical equipment. Purthermore, all configurations shall comply with System Standard IEC 60601-1-1. Anyone connecting additional equipment or otherwise causing a different system configuration than provided by Alcon is responsible for continued compliance to the requirements of System Standard IEC 60601-1-1. If in doubt, consult the Technical Services department or your local Alcon representative. Follow Jocal governing ordinances and recyeling plans regarding disposal or recycling of device components and packaging. User Information - Environmental Considerations The equipment that you have purchased requires the use of natural resources for its production. This equipment may also contain hazardous substances which could have potential effect on the environment and human health if disposed of improperly. In order to avoid the entry of any such substances into our environment and to pro- mote natural resource conservation, we encourage you to use the appropriate take- back systems. Such take-back systems reuse or recycle many of the materials in your end-of-life equipment in a beneficial way. Please contact your local Alcon office for assistance int take-back options through Alcon or other providers. ‘The crossed-bin symbol located on this equipment reminds you to use take-back sys- tems, while also emphasizing the requirement to collect waste equipment separate and not dispose of it as unsorted municipal waste. The Pb notation, if present, indi cates that the labeled device contains greater than 0.004% lead. Pb If you need more information on the collection, reuse or recycle systems available to you, please contact your local or regional waste administration, or contact your local Alcon office for more information. Universal Precautions Universal precautions shall be observed by all people who come in contact with the instrument and/or accessories to help prevent their exposure to blood-borne pathogens and/or other potentially infectious materials, In any circumstance, wherein the exact status of blood or body fluids/tissues encountered are unknown, it shall be uniformly considered potentially infectious and handled in accordance with OSHA or your own. national guidelines. 3088751606 13 oNer EMC Statement Itis important to install and use the equipment in accordance with the instructions in order to prevent harmful interference with other devices in the vicinity. If this equipment causes harmful interference to other devices (determined by turning the equipment off and on), the user is encouraged to try to correct the interference by one or more of the following mezsures: + Reorient or relocate the other device(s). + Increase the distance between the equipment. + Connect this equipment into an outlet on a circuit different from that to which the other device(s) is connected. + Consult the manufucturer or your Alcon field service engineer for help. Table 1-1 Guidance and Manufacturer's Declaration - Electromagnetic Emissions - The Infinit Vision Systom is intended for use in the electromagnetic environment specified below. The customer or the user of the Infinit® Vision System should assure that it is used in such an environment. Emissions Test Compliance | Electromagnetic Environment-Guidance RF emissions Group |_| Tho infini# Vieion Vision System uses RF energy only for its intornal CISPR 11 function, Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class A | Basedon extensive field experience the Infinit Vision System is suitable CISPR 11 forusein all establishments including domesticand those diractiy connoctod |} to the public low voltage power supply network that supplies buildings Harmonic omissions Class —_| used for domestic purposes. IEC 61000-9-2 EEERERS Mees SEEESEES ‘The EMC Statement provides guidance on steps to take in case of Voltage fluctuationsy Complies | electromagnetic interference. Flicker emissions IEC 61000-3-3 14 8065751606 Guidance and Manufacturer's Declaration - Electromagnetic Immunity - The Infiniti Vision System is intended for use in the electromagnetic environment specified below. The customer of the user of the Infinit Vision System should assure that it is used in such an environment. Immunity Test _ |IEC 60601 Test Level] ‘Compliance Level _|Electramagnotic Environmont-Guidance Electrostatic + 36 kV contact + 46 KV contact Floors should be wood, conerete, or ceramictile. Do discharge (ESD) f+ 48 kV air + 48 KV air notuse around floors thatare covered with synthelic IEC 61000-4.2. material lo avoid system sloppage due to ESD. Electrical fast I+ 42 kV forpowar | 42 KV for power | Mains power quality should be that of a typical transienvourst supply ines suppl lines Jcommercial or hospital environment. To avoid pre- 1EC61000-4-4 — + 47 KVforinouy f+ 21 KV for input’ —_ | maturo shutdown duetofasttransientsavoldpoworing ‘output ines | output lines the Infinif® Vision Systom on tho same branch circuit with sources thal can generale fast transients (inductive switching: e.g., high current motors). Surge | #1 kv dierentia! |» 21kV diferantial [Mains power quality should be that of a typical IEC 61000-4-5 mode commercial or hospital environment + #2 KV common mode Voltage dips, short |+ <5% U, (95% dip in| <5% U, (86% dip in| Mains power quality should be that of a typical interruptions, and | U,) for 0.5 cycle U)forb.5 cycle | commercialorhospital environment. Ifthe useofthe voltage variations |+ 40% U, (60% cip in |+ 40% U, (60% dip in_ | infinid® Vision System equires continued operation ‘on power supply | U,) for’ cycles U,) for cycles during power mainsinterruptions, itis recommended input lines: + 70% U, (30% dipin |+ 76% U, (30% dip in. | that the infint® Vision System be powered from an IEC 61000-4-11 U,)for 25 cycles | U)for 25 cycies_| uninterruptible power supply or a battery. + 95% dip in}+

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